Boston Scientific Recalls AXIOS Stent and Delivery System Over Deployment Failures

What Happened

Boston Scientific Corporation has initiated a voluntary recall of the AXIOS Stent and Electrocautery-Enhanced Delivery System. The recall follows an increase in reports regarding stent deployment and expansion issues. According to the FDA, these malfunctions can lead to the prolongation of medical procedures as clinicians exchange the faulty device for a new one. In more severe cases, the inability to deploy or expand the first flange could necessitate additional endoscopic or surgical interventions to remove the stent and close the puncture site.

Which Products Are Affected

The recall affects 39 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm.

• Material Number (UPN): M00553680
• UDI-DI: 191506008086
• Recall Number: Z-1159-2026
• Affected Lot Numbers: 35950784, 35960771, 35960772, 36156260, 36156261, 36165653, 36167912, 36241714, 36401105, 36408034, 36421237, 36447549, 36447550, 36520894, 36530482, 36530483, 36530484, 36533326, 36536257, 36536258, 36570788, 36570789, 36578110, 36581584, 36603297, 36611362, 37014108, 37429734, 37429735, 37433804, 37433805, 37440329, 37451303, 37456593, 37495326, 37511241, 37519092, 37519093, 37780825.

The distribution of these units is worldwide, including the United States (nationwide and Puerto Rico) and over 50 other countries across Europe, Asia, South America, and the Middle East.

What You Should Do

This is a firm-initiated voluntary recall. Healthcare facilities and providers in possession of the affected lots should follow the instructions provided by Boston Scientific Corporation. For further information or to coordinate the return of affected products, providers can contact Boston Scientific at their Marlborough, MA headquarters located at 100 Boston Scientific Way, Marlborough, MA 01752-1234.

Why This Matters

The FDA has classified this as a Class I recall, the most serious category, indicating that the use of these devices could result in serious health consequences or the need for emergency surgical intervention to address deployment failures.

Source

Information provided by the FDA.